FDA Comments 2

Note: The following letter was sent December 26th, signed for and received by the FDA on December 27th.  As more letters arrived on the 27th, a second package with the latest tallies was sent to the FDA on December 27th and received and signed for by the FDA on December 28th.  Letters continue to arrive at our offices beyond the deadline, however we will still compile the information and send them to the Dept of HHS and CDC.  They do not have a deadline.

(On CoG for Life Letterhead)

December 26, 2006

Division of Dockets Management HFA-305

Food & Drug Administration

5630 Fishers Lane Room 1061

Rockville, MD  20852

Ref: Docket Number 2006D-0383:

Guidance to Industry for Development of Cell-Based Viral Vaccines

Dear FDA:

Enclosed for your review are 6,185 signatures from citizens across the country writing in response to the proposed Industry Guidance for Development of Cell-Based Viral Vaccines, FDA Docket, 2006D-0383.  These signatures were gathered by Church organizations, pro-life groups and concerned families who wish to formally register their names and comments, protesting the use of aborted fetal cell lines in vaccine development.  They have been sent to Children of God for Life so that all data could be compiled and tallied.  Due to the Christmas holiday season and a fear of mail delays, we understand many chose to write to you directly as well.

In addition, we tracked through a pre-registration on our website over 5,500 public comments tallied through the FDA on-line commenter, as well as another 10,189 signatures gathered from several NY Districts, plus several hundred personal letters and post cards – totaling over 22,000 letters from citizens both here in the US and at least 16 foreign countries.

These families all share the same concerns voiced by professional, pro-life and religious groups in the letter copies enclosed that were mailed directly to the FDA, with copies sent to our organization as well.

Children of God for Life would especially like the FDA to take notice of the comments filed by the National Catholic Bioethics Center, which is the consulting arm for the United States Conference of Catholic Bishops.  They have asked you to ban the use of aborted fetal cell lines in future products and likewise, will advise over 63 million American Catholics of this proper Catholic moral position.

While we understand that the FDA guidelines are proposed recommendations, nowhere in those guidelines have you addressed the need for consideration of the ethical concerns of using aborted fetal cell lines.  The Federal Government has an obligation to advise the pharmaceutical industry of these concerns prior to their development of any new vaccines, therefore at a minimum, we would expect it to be added to the guidelines.

In closing, we are asking you to share the thousands of letters you have received with the pharmaceutical industry as they have a vested interest in knowing that a large portion of their potential market will refuse any vaccines produced using aborted fetal cell lines.  One does not have to morally minded to understand the significant impact this could have on the health and safety of the population as the public becomes increasingly aware of this issue.  We ask you to carefully consider these concerns in the approval process of all new immunization products, since no vaccine can be safe or truly effective unless a sufficient number of the population is protected.

Sincerely,

Debra L. Vinnedge

Executive Director

CC:      Julie L. Gerberding, Director, Centers for Disease Control

Michael O. Leavitt, Secretary US Dept HHS